FDA Clears IND for Phase 2 Trial of Injectable rhPDGF-BB for Infraorbital Hollowing
Key Takeaways
The FDA has cleared an Investigational New Drug (IND) application for Lynch Regenerative Medicine's Phase 2b clinical trial evaluating injectable rhPDGF-BB for infraorbital hollowing, according to a press release.
The multicenter, randomized, dose-ranging study will enroll up to 75 adults, evaluating safety and improvement on the Canfield Infraorbital Hollowing Scale at 12 weeks among the primary endpoints.
The investigational injectable is being studied as a potential regenerative alternative to traditional tear trough fillers, although its safety and efficacy for this indication have not been established.
Lynch Regenerative Medicine (LRM) announced that the US Food and Drug Administration (FDA) has authorized its Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating injectable recombinant human platelet-derived growth factor-BB (rhPDGF-BB) for the treatment of infraorbital hollowing, commonly known as tear trough hollowing.
The multicenter, randomized, dose-ranging study seeks to evaluate the safety, tolerability, and preliminary efficacy of rhPDGF-BB injections in up to 75 adults with infraorbital hollowing, a cosmetic concern associated with age-related loss of tissue support beneath the eyes, the manufacturer said. Primary endpoints include safety and changes on the Canfield Infraorbital Hollowing Scale at 12 weeks. Secondary assessments will look at infraorbital tissue quality using validated patient-reported outcome measures and quantitative image analysis, along with pharmacokinetic and immunogenicity profiles.
Phase 2 Trial to Assess Safety and Infraorbital Volume Improvement
The investigational treatment uses rhPDGF-BB, a previously studied growth factor that has been used in other therapeutic settings. LRM is evaluating whether injectable rhPDGF-BB can improve infraorbital contours through tissue regeneration rather than conventional filler-based volume replacement. According to the press statement, the injectable formulation is distinct from the company's marketed topical cosmetic product, ariessence pure PDGF+, which contains rhPDGF-BB and hyaluronic acid.
"Patients and practitioners continue to seek safe, effective, and durable bioregenerative options for improving volume deficiency and contour irregularities in the tear trough region," said Steve Yoelin, MD, the study's principal investigator.
Enrollment is expected to begin within several weeks, according to the company.
Source
Lynch Regenerative Medicine news release. October 21, 2026.